BEUDAMED
    FDA Enforcement Class II Terminated

    BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.

    Recall: Z-1358-2016 · Reported April 20, 2016

    Enforcement

    Recall Number
    Z-1358-2016
    Event ID
    72922
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    C.R. Bard, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 20, 2016
    Initiation Date
    December 18, 2015
    Classification Date
    April 8, 2016
    Termination Date
    June 29, 2016
    Address
    8195 Industrial Blvd NE, N/A, Covington, GA, 30014-1497, United States

    Description

    BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.

    Reason

    Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.

    Code Info

    Code(s): Catalog numbers: 01655SI12, 01655SI14, 01655SI16, 01655SI18, 01655SI20, 01655SI22, 01655SI24, 01655SI26, 01655SI28 and 01655SI30. All lot numbers produced with IFU (PK7634040) are affected.

    Distribution

    Distributed US (nationwide) and the countries of Canada and Australia.

    Quantity

    1,428,000 units (total)